To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if there is a higher incident of expression of the SCN9 gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus.

To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device [ Time Frame: Single visit (day 1), assessed at time of visit ] [ Designated as safety issue: No ]

The Inhibitor™ Tinnitus Masking Device will be demonstrated for a duration of 60 seconds and may be demonstrated up to 5 times on individuals presenting with tinnitus to evaluation any changes in tinnitus perception. Duration and degree of change will be recorded for each presentation of the device.

Secondary Outcome Measures:

Genetic Sample to look for particular genetic expression. [ Time Frame: Single visit (day 1), evaluated at the time of the genetic collection. ] [ Designated as safety issue: No ]

Individuals with and without (to serve as controls) may provide a genetic sample (via blood, buccal swab or saliva) to determine presence of SCN9 gene expression. This genetic expression is associated with chronic pain. Since chronic pain and tinnitus are similar, we are trying to determine if there is a higher incident of expression of the SCN9 gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus. Those without tinnitus will serve as controls.

Up to 50 million Americans have tinnitus on a regular basis with between 2-3 million suffering from tinnitus where it affects daily living. The Inhibitor™ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitor™ Tinnitus Masking Device. Patients may provide a genetic sample (typically via saliva sample) to look for expression of a particular genetic marker that may be associated with tinnitus. The investigators will be collect samples from both people with tinnitus and those without tinnitus to use as a control.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

over 18 years,

has tinnitus

Exclusion Criteria:

Pacemaker,

pregnancy,

metal implants in head or neck,

thrombosis, migraines/headaches,

metal bonded retainer, surgeries within the last 6 months which patient is still recovering from,

any medical reason your physician would advise against the use of this device,

under 18 years

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412918